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NRG-HN005, “A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, p16-Positive, Non-Smoking Associated Oropharyngeal Cancer,” is temporarily closed to accrual as broadcasted on February 03, 2023.
The results of the scheduled interim futility analysis comparing experimental Arm 2 (60 Gy radiation plus cisplatin) to the control Arm 1 (70 Gy radiation plus cisplatin) for the randomized phase II portion of the study, showed that Arm 2 did not achieve the non-inferiority threshold per the protocol’s statistical analysis plan.
This temporary closure is not related to any safety issues. Instructional letters for site investigators and patients (Dear Investigator and Dear Participant Letters dated February 06, 2023) are posted on the CTSU website.
Please distribute this information to the appropriate personnel at participating affiliate institutions.
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